Efficacy of Low-dose Percutaneous Electrical Stimulation in Patients With Erectile Dysfunction.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-01

Study Completion Date

2026-02-28

Brief Summary

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Erectile dysfunction is known as any alteration that produces a modification in the erectile response, whether it is due to organic, psychogenic or relational causes. Peripheral percutaneous nerve stimulation is performed using a needle to stimulate the peripheral nerves in such a way as to stimulate most of the area of the structure, stimulating sensory and motor nerve endings in the deeper tissues.

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Detailed Description

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Patients will undergo continuous stimulation at a frequency of 20 Hertz, a pulse width of 200 µs and for a total of 20 minutes. The intensity will be set at the maximum tolerated by the patient, observing significant changes in erectile function after transanal stimulation at intensities between 20 and 100 mA.

Conditions

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Pudendal Nerve Injury Erectile Dysfunction Electric Stimulation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

The study corresponds to a non-randomized, single treatment arm, prospective, multicenter study. The subject, the assignor, the physiotherapist, the statistician and a person in charge of activating the protocol will know the stimulation parameters, to adjust, monitor and apply the treatment.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group I

The intervention protocol for Group I peripheral nerve electrostimulation will have the following parameters:

Patients will be intervened with stimulation continuously, at a frequency of 20 Hertz, a pulse width of 200 µs and for a total of 20 minutes. The intensity will be set at the maximum tolerated by the patient.

Group Type EXPERIMENTAL

Low Dose

Intervention Type OTHER

Patients will be intervened with stimulation continuously, at a frequency of 20 Hertz, a pulse width of 200 µs and for a total of 20 minutes. The intensity will be set at the maximum tolerated by the patient.

Interventions

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Low Dose

Patients will be intervened with stimulation continuously, at a frequency of 20 Hertz, a pulse width of 200 µs and for a total of 20 minutes. The intensity will be set at the maximum tolerated by the patient.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Males Ages between 18-60 years old

Primarily organic cause diagnosed by Doppler:

* Peak-systolic velocities (PSV).
* Tele-diastolic velocity (DTV).
* Resistance Index (RI) Patients with ≤ 6 months since first assessment. Initial IIEF-EF questionnaire scores: 11-25 points. (mild to moderate erectile dysfunction) Active sexual life (more than 4 attempts per month).